New Delhi: Delhi health minister Satyendar Jain on Wednesday said that over 2,000 people have benefitted from plasma therapy in Delhi, a day after reports that Centre was considering to remove it from clinical management protocol for the coronavirus disease (Covid-19),
“A study done by ICMR and AIIMS did not see any breakthrough maybe. But our trial is underway and it is of course being done with the permission of ICMR. We have seen benefits of the therapy, with over 2,000 people having received convalescent plasma from our bank at ILBS. I have myself benefited from the therapy,” said Jain in an interaction with media.
ICMR had conducted a pan-India study to determine the role of plasma therapy, and the Union health ministry had added it as one of the investigational therapies in the national protocol for treating Covid-19 patients.
However, Dr Balram Bhargava, director general, India Council of Medical Research (ICMR) had said on Tuesday, “We have had discussions at the National Task Force (NTF) and we are discussing further with the Joint Monitoring Committee. This (plasma therapy) may be deleted from the national guidelines.”
The trial conducted by the Indian Council of Medical Research across 39 sites for the effectiveness of the therapy in Covid-19 patients, showed that there were no difference in the proportion of patients who progressed to severe disease and those who died between the group that received convalescent plasma and the other who received standard care without plasma.
Convalescent plasma therapy is a well-established method used to treat infections and autoimmune diseases. For Covid-19, a blood component called plasma that is rich in virus-fighting antibodies is taken from patients who have recovered and given to those still fighting the infection.
AAP national spokesperson Raghav Chadha said the removal of the therapy from the protocol would be a “perfunctory act”. “To remove Convalescent Plasma Therapy from Clinical Management Protocol based on a single study (i.e. ICMR Trial) in which even antibody titers of the plasma were not taken into account is a perfunctory act — in a situation where no definitive therapy exists till date,” Chadha tweeted.
“The world’s largest observational study on Convalescent Plasma Therapy conducted on 35,322 Covid patients by Mayo Clinic reported favorable outcomes with lower mortality in patients who received the therapy early in the course of disease with higher levels of antibodies,” he tweeted.
The study by Mayo clinic shows that the seven-day mortality rate reduced in patients transfused within three days of diagnosis as compared to those who were given the therapy later, especially if the donor had high levels of antibodies.
Reviewing the effectiveness of the therapy, Dr Manish Soneja, additional professor in the department of medicine at AIIMS, said, “The PLACID trial from India shows that the results were pretty similar in the group that received plasma therapy and the group that was given standard care. There were some limitations of the study such as many of the patients who were given the therapy already had high levels of neutralising antibody (that prevents the spread of a particular virus, Sars-CoV-2 in this case) at admission. However, this replicates the real-life situation with the facility for testing for neutralising antibodies not available in most places.”
“As for globally, a Chocrane (a library of collated medical evidence) that has looked at 19 studies shows that the therapy is not effective in reducing the all cause mortality. Improvement in clinical symptoms wasn’t really there,” he said.
However, after ICMR had released the data from its trial Dr SK Sarin, director of Institute of Liver and Biliary Sciences (ILBS) which is coordinating Delhi’s plasma trial said, “The ICMR study actually reconfirms the findings of our small study – it shows that the oxygen requirement went down in the patients who received plasma therapy, the duration for which they remained breathless reduced, and the group that received plasma tested negative for the virus quicker than the control group. What needs to be factored in is that the therapy was administered late, after two days of symptoms in most trial participant; it works best when given early. Also, many of the donors in the study did not have a high titre (concentration) of the neutralising antibodies,” Dr Sarin had said.
“For the study, the all-cause mortality at 28-days has been considered, I think a shorter duration has to be chosen because mortality could be because of other complications as well,” he said.
A large-scale study of 400 participants is currently underway at Lok Nayak hospital and Rajiv Gandhi Super Speciality hospital in collaboration with ILBS.